Applying for Authorization

The pharmaceutical company must complete and submit to the Commissioner of Patents an  Application for Authorization Under Section 21.04 of the Patent Act. The form sets out the information that must appear in the application, including

• the pharmaceutical product for which an authorization is being sought;
• the quantity to be manufactured;
• the patent or patents that protect the pharmaceutical product;
• the country to which the pharmaceutical product is to be exported; and
• the identity of the purchaser.